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Today’s Big News

Feb 18, 2025

Trump administration layoffs hit FDA’s device center

2 NIH leaders depart as White House cuts thousands of jobs across federal health agencies

2024's top 10 clinical trial flops

Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drug

With new FDA approval, GSK joins Pfizer in the 5-in-1 meningococcal vaccine ring

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Trump administration layoffs hit FDA's device center

By Conor Hale

It’s unclear how many staff at the FDA have been affected. There have also been estimates of thousands of dismissals spanning the NIH, the CDC and other agencies across the HHS.

2 NIH leaders depart as White House cuts thousands of jobs across federal health agencies

By Gabrielle Masson

The National Institutes of Health has lost two distinguished leaders as mass layoffs directed by the Trump administration hit federal health agencies.

2024's top 10 clinical trial flops

By James Waldron

Fierce Biotech recounts the top 10 clinical trial failures of 2024 that sent ripples across the industry.

Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drug

By Darren Incorvaia

After its potential kidney disease drug went down in flames late last year, Novo Nordisk is pinning the blame on alleged fraudulent claims by the drug’s original maker. The Danish pharma giant plans to seek $830 million in damages from Singapore-based KBP Biosciences and KBP’s founder and executive chairman, Zhenhua Huang, Ph.D.

With new FDA approval, GSK joins Pfizer in the 5-in-1 meningococcal vaccine ring

By Zoey Becker

The company's Penmenvy combines components of its established MenB and MenACWY vaccines Bexsero and Menveo, respectively.

J&J MedTech restarts Varipulse's US rollout after stroke reports

By Conor Hale

J&J said it found no immediate procedure-related causes from the atrial fibrillation therapy but that risks can escalate if a high number of consecutive ablations are delivered.

Argenx puts marketing muscle behind CIDP launch with Vyvgart Hytrulo TV campaign

By Nick Paul Taylor

Argenx is urging patients to “Live Vyvidly.” The biotech put the message out in a direct-to-consumer TV ad that paints Vyvgart Hytrulo as a drug that can help people with chronic inflammatory demyelinating polyneuropathy live life to the fullest.

FDA approves Ono's rare tumor drug from $2.4B Deciphera buyout

By Angus Liu

The new FDA approval gives Daiichi Sankyo’s Turalio some company in a rare tumor type.

Solid Bio's stock soars as early DMD gene therapy data beat expectations

By Nick Paul Taylor

Solid Biosciences has surged back into the Duchenne muscular dystrophy gene therapy race. The biotech reported expectation-busting phase 1 data on its next-generation candidate, sending its stock spiraling upward.

FDA signs off on Sanofi's insulin biosimilar, the first for Novo Nordisk's rapid-acting NovoLog

By Kevin Dunleavy

The FDA has given a thumbs up to Sanofi’s Merilog as the first biosimilar substitute for Novo Nordisk’s NovoLog for patients with diabetes. It is delivered by a subcutaneous shot 5 to 10 minutes before mealtime to help patients manage glucose and limit blood sugar spikes.

Fierce podcasts

Don’t miss an episode

A heartwarming review of cardiovascular news, most-loved stories

This week on "The Top Line," we celebrate Valentine's Day with a discussion about heart-related updates and the stories we've loved covering so far this year.